A drug for advanced kidney cancer developed by Onyx Pharmaceuticals and Bayer has been given a green light by the European Medicines Agency (EMEA).
Nexavar (sorafenib tosylate) has been cleared in Europe for use in advanced renal cell carcinoma (RCC) patients who have failed prior or are ineligible for therapy with interferon alpha or interleukin-2-based drugs. The drug got the go-ahead for this indication in the USA last December.
The drug is the first oral multi-kinase inhibitor to reach the market and is one of the stars of Bayer’s product pipeline, with peak sales expected to top 1 billion euros, assuming it also wins approval in follow-up indications such as skin, liver and lung cancers. Aside from the USA, it has also been approved in Mexico, Chile, Brazil, Korea and Switzerland.
In trials, Nexavar, has been shown to double progression-free survival of patients from three to six months on average, but it also appears to be much less toxic than current treatments for this type of cancer, including IL-2 and IFN alpha, and has the additional benefit of being dosed orally rather than by injection.
Bayer and Onyx said in a joint statement that more than 200,000 people around the world are diagnosed with kidney cancer a year and more than 102,000 die from the disease. In Europe there are more than 46,000 new cases of kidney cancer annually.